Regulatory Surveillance Summary for June 2018
European Federation for Cosmetic Ingredients (EFfCI) European Federation for Cosmetic Ingredients (EFfCI) Good Manufacturing Practice (GMP) for Cosmetic Ingredients, Revision 2017 This document incorporates existing GMP principles, World Health Organization (WHO) GMP Guidelines for Excipients, International Pharmaceutical Excipients Council (IPEC) GMP for Bulk Pharmaceutical Ingredients 2006, and International Quality Management System requirements as developed […]
Regulatory Surveillance Q1 2017 | Drugs, Devices, Biologics, Cosmetics, & Over-the-Counter Drugs
European Federation for Cosmetic Ingredients (EFfCI) No updates noted as of 09 March 2017 European Medicines Agency (EMA) Guideline on the Chemistry of Active Substances, 15 November 2016, EMA/454576/2016 The European Medicines Agency (EMA) has published a “Guideline on the Chemistry of Active Substances,” setting out information required by Directive 2001/83 with respect to the […]
The New ISO 13485:2016 Standard: What You Need to Know
You may be in the process of upgrading your Quality Management System to the new ISO 9001:2015 requirements, but don’t forget that there are new changes to the ISO 13485 standard as well! Unlike the drastic overhaul witnessed during the ISO 9001 transition, the structure of the new ISO 13485 standard remains the same as […]